The primary objective of this phase-II study is to assess the toxicity of consolidation intensity-modulated whole-abdominal radiotherapy using tomotherapy in patients with advanced optimally debulked stage International Federation of Gynecology and Obstetrics (FIGO) III ovarian cancer with a complete remission after adjuvant chemotherapy. 36 patients will be treated to a total dose of 30 Gy in 1.5 Gy fractions. The planning target-volume includes the entire peritoneal cavity and the pelvic and para-aortal node regions. Intensity-modulated whole-abdominal radiotherapy allows an effective sparing of liver, kidneys and bone-marrow (vertebral bodies and pelvic bones).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Consolidation intensity-modulated whole-abdominal radiotherapy using helical tomotherapy to a total dose of 30 Gy in 1.5 Gy fractions
Department of Radiation Oncology, University of Heidelberg
Heidelberg, Germany
RECRUITINGcompatibility of the treatment
Therapy compatibility defined as non-occurrence of life-threatening grade 4 (CTCAE v3.0) acute toxicity
Time frame: Beginning of radiotherapy till 6 weeks after its completion
Rate of incomplete radiotherapy
Rate of incomplete radiotherapy due to treatment toxicity
Time frame: 4 weeks
Rate of delayed radiotherapy
Rate of delayed radiotherapy due to treatment toxicity
Time frame: 4 weeks
Acute toxicity
Graded according CTCAE Version 3.0
Time frame: From the beginning of radiotherapy till 6 weeks after its completion
Late Toxicity
Graded according CTCAE Version 3.0
Time frame: 6 weeks -3 years after the completion of radiotherapy
Overall survival
Time frame: 3 years
Disease-free survival
Time frame: 3 years after the completion of radiotherapy
Quality of life
assessed using EORTC QLQ-C30 Questionnaire
Time frame: 3 years
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